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Online Memory Intervention for Traumatic Brain Injury
N/A
Recruiting
Led By Robin E Green, PhD; CPsych
Research Sponsored by Toronto Rehabilitation Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute care diagnosis of m-sTBI
Between 18 to 55 years of age
Must not have
Diagnosis of a neurodevelopmental disorder
TBI sustained before age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during each of the 80 session (5 sessions/week, 16 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if an online game can help improve memory and brain health for people who have had a moderate-severe brain injury.
Who is the study for?
This trial is for individuals aged 18-55 who have had a moderate to severe traumatic brain injury, confirmed by CT or MRI. Participants should be fluent in English, able to give consent (or have someone who can), and must live near Toronto for MRI access. They need basic computer skills and the ability to use at least one arm.
What is being tested?
The study tests an online program designed to improve memory through spatial navigation exercises versus educational videos. It aims to see if this method is effective and practical for those with traumatic brain injuries.
What are the potential side effects?
Since the interventions are non-invasive, consisting of an online program and educational videos, significant side effects are not anticipated. However, participants may experience fatigue or frustration during tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a moderate to severe traumatic brain injury recently.
Select...
I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a neurodevelopmental disorder.
Select...
I had a traumatic brain injury before turning 18.
Select...
I have been diagnosed with aphasia.
Select...
I have a neurological condition other than traumatic brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected during recruitment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during recruitment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance
Change in Digit Span score
Change in Everyday Memory Questionnaire score (far transfer)
+17 moreSecondary study objectives
Change in How Much Is Too Much scale score
Feasibility: Compliance rate
Feasibility: Recruitment rate
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Spatial navigation interventionExperimental Treatment1 Intervention
Group II: Educational VideosActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Toronto Rehabilitation InstituteLead Sponsor
54 Previous Clinical Trials
5,942 Total Patients Enrolled
Ontario Neurotrauma FoundationOTHER
23 Previous Clinical Trials
1,043 Total Patients Enrolled
Centre for Aging and Brain Health InnovationOTHER
15 Previous Clinical Trials
5,116 Total Patients Enrolled
Robin E Green, PhD; CPsychPrincipal InvestigatorToronto Rehabilitation Institute
Asaf Gilboa, PhDPrincipal InvestigatorBaycrest Health Sciences